Thursday, August 20, 2009

HPV/Gardisil vaccine clears major safety hurdle

In the August 19, 2009 issue of the Journal of the American Medical Association, a major review of the safety of Gardisil (the vaccine against human papilloma virus first licensed in 2006)was published. This is the first publication of a comprehensive analysis of all the data by the Centers for Disease Control and the FDA. It is based on the data collected by the VAERS (Vaccine Adverse Events Reporting System). This means that this is a safety report based on the track record of this vaccine AFTER it was approved and has been administered over 23 million times.

VAERS is a national, government-sponsored reporting system. All reports (12, 121 for Gardisil) are screened and any serious problems are thoroughly investigated. Most reports were minor (fainting--at the same rate as tetanus shots; dizziness;nausea;headache;and local reactions)

Thirty two reports of deaths were made of which only two are still being investigated as possibly caused by the vaccine. All others were serendipitous (caused by diabetes, illicit drug use, viral illness, or heart failure none of which were linked to the vaccine).

All in all the safety record appears very similar to the data that was presented from pre-licensing trials. The only major change I have implemented in my office has been to watch girls for an extra ten minutes after their shot to guard against a dangerous fall from a fainting spell.

It is good to remember that about 11,000 women are diagnosed with cervical cancer each year in the US alone. About 4000 die from the disease each year. The HPV vaccine effectively protects against the main types of virus that cause 70% of these cancers.

In the global picture where folks across the world are dying at alarming rates of the common illnesses of diarrhea, malaria, influenza and pneumonia it may seem a luxury to vaccinate against a relatively rare disease with a relatively expensive vaccine. I remind patients that we ARE lucky to have this vaccine. Just as we are lucky to have good education, roads, and other amenities of a "developed" country. But let us also remember that American minority women still contract and die from cervical cancer at much higher rates than Caucasian women. Research shows that this discrepancy is due to a problem of access to medical care-- as we know a thorny problem that our country has yet to solve.